In brief perspective, after 2,000 years and efforts from the best medical and research institutions using the most advanced technology available anywhere in the world, the actual processes and causes of Celiac, gluten sensitivities, and many other life threatening and taking diseases with origins in the gut, such as those resulting from gluten or other protein effects, remain unknown today. The fecal-oral cycle of pathogens entering the digestive tract has greatly increased in the U.S., due somewhat to more food sources from other countries, where sanitation is practiced less. Now, microbial diseases of the gut rank second in humans only to the respiratory system. While in vivo sampling of the respiratory and cardiovascular fluids is routinely performed with minimal cost, patient inconvenience, and time consumption, sampling of the gastrointestinal tract via endoscopic and colonoscopy procedures are more intrusive, costly, and more importantly of limited value or scope. It is estimated that of the more than 10,000 strains of bacteria, perhaps numbering well over a trillion in total number in the GI tract, less than 5% have even been identified/isolated, much less characterized within the gut or other environment. Much of the most important regions of the gut, first of all, are inaccessible for in vivo samples. As in virtually all in vivo sampling of the human body, analyses are performed in vitro. Once again, procedures for testing of gut matter, especially below the stomach, are in vitro collected samples and in vitro analyzed. Since not only is the second highest frequency of human diseases associated with the gut, arguably, the most serious and over a period of time, the highest number of serious diseases originate in the gut directly, or indirectly as a result of conditions within the gut. This should place extremely high national priority upon developing the capability of efficient, cost-effective, and technically-effective gut sampling and diagnostic capabilities. This invention is based upon addressing this national, and world-wide, need for improving human health. It is hoped that the research that led to this invention will also go far beyond the in vivo sampling of gut matter, and also lead to in vivo analysis and in vivo treatments of patients with a wide variety of illnesses and diseases in a relatively unobtrusive manner. The first invention by Shuck (U.S. patent Ser. No. 13/691,169), of which this is a continuation, is a serious accomplishment toward this overall objective, and the herein disclosed invention is step two, in the overall research and technology development scheme with the above stated goals.
These esoteric processes taking place in heretofore inaccessible regions of the gut contribute and lead to various stages of many diseases over several years in humans, and the initial, intermediate, and terminal stage symptoms all vary widely among human subjects. Implicit in this statement, and patient evidence, is that there are many, as in tens of thousands, of variables involved. Furthermore, these variables are not just of one scientific discipline, but several disciplines and the harmful effects are suspected of being caused by the interaction and creation of new variables resulting from the interaction or coupling of different scientific discipline based variables. An important implication is that due to the many variables, and the many disciplines combined, most of the research methodology used throughout history of correlating some phenomena using mostly statistical correlation methods, will never solve the mysteries of diseases associated with such protein digestion related processes, or other diseases with origins in the gut. The 2,000 year plus mystery is sufficient testimony.
Most research on Celiac and gluten sensitivities has been from individual disciplines of microbiology, gastroenterology, genetics, molecular biology, cellular biology, dietetics, bacteriology, biochemistry, immunology, allergy, toxicity, digestion, nutrient absorption, anatomy, physiology, etc. Naturally, since these problems are human health problems, they are researched primarily individually by the broad spectrum of disciplines associated with the human body and human health, and peripheral associated sciences and industries, such as pharmaceuticals. Unfortunately, there are many more disciplines that should be involved, but not significantly represented in Celiac and gluten-related disease research alone. Even the research methodology itself has been extremely limited because of the lack of appropriate technology. Also, the complex phenomena leading to so many different symptoms and diseases is believed to be of a more fundamental and complex “protein conversion process” nature, rather than just gluten, or some single antigen that provokes the autoimmune system. As reflected by the named disciplines above, most research also falls into investigation of the micro world level of processes. Even among the medical science disciplines, much research is mono-disciplinary, and very little research incorporates simultaneously variables from a variety of medical science disciplines. In reality, the esoteric nature of these diseases is hereby hypothesized to be a function of many variables from both the micro and macro world and spanning many disciplines. This narrow research methodology being practiced, however, is reflective of the world-wide culture of research. For a variety of reasons, researchers routinely do not reach out across disciplinary barriers. This is not productive in studying the gut!
On the contrary, the herein disclosed invention is associated with a broad research agenda based upon creating the capability for multidisciplinary research across many disciplines, even those far removed from the medical sciences, and involving both micro and macro world variables. In fact, the broad research scope is predicated upon proving that at least some of the significantly contributing variables are from non-medical sciences. In particular, such engineering sciences as fluid dynamics, mass and energy transport processes, diffusion and dispersion in porous permeable media, surface phenomena, boundary layer phenomena, physical chemistry, bio-reaction kinetics, surface chemistry, physical chemistry, etc. and all of the variables so defined within these disciplines are seldom if ever mentioned, much less, incorporated into the hypothesized, diagnostic or solution methodologies, or in any known models. In fact, models are not even considered as a rule, just some statistical correlation among symptoms variables.
Not only are these “other discipline” variables significant, but it is herein hypothesized that the products of the interactions of the “other” and “medical” discipline variables is where the causes and solutions will be found. These are the guiding principles which led to this broad spectrum research effort. The invented devices disclosed to date have the embodiments of Capsules A, B, and AB, and will be summarized with focus upon the herein disclosed invention of Capsule B. Further reference to research preceding this invention as in reference to Capsule A, and the broader research effort, may be found in the U.S. patent Ser. No. 13/691,169 by Shuck entitled, “Human Intestinal Tract Research and Diagnostic System To Evaluate Patients And Advance Medical Science And Bioengineering And To Determine Processes In The Gut And Causes Of Diseases”. The ultimate goal, of which this invention is just one step, is of course to be able to cure many human diseases. Instrumental to this overall objective, is to generate the data and knowledge base for creating a biomedical-engineering model of the human gut encompassing all of the microbial-assisted, biochemical reactions and mass and energy transport processes. The innate nature of the gut is probably the world's greatest treasure of compact and diversified data spanning the nano to macro scale, and perhaps incorporating more disciplines of science and engineering than any other one object or functioning system on earth. By virtue of such already existing Big Data sets and the statistical combinatorial properties possible, such as factorials, permutations, and combinations, of the combined intrinsic gut system components and properties, along with appropriate definitions of hundreds of variables and their individual data sets throughout the GI tract, it constitutes a researchers dream world, yet stretches the limits of technologies when considering an appropriately designed research system and methodology for exploring, mining, and analyzing such data. That is the system, the challenge, and the perspective for this research effort.